Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00157

2 Trial Registration Date

2008-03-20

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Departmental funding from DOVS, CUHK ( for the drug bevacizumab (avastin))

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Felix CH Li

ii Address

iii Phone

xil@dr.com

iv Email

email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Dennis SC Lam

ii Address

iii Phone

dennislam_cu_res@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Phaco-trabeculectomy with adjunctive intra-vitreal injection of bevacizumab (Avastin). A preliminary study

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2008-02-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Glaucoma

15 Intervention

i Types of intervention

Other

Please specify

Drug+Procedure

ii Description/ name of Intervention/article

Phaco-Trabeculectomy with intravitreal injection of Bevacizumab (Avastin)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

60-90 min

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

No control or comparative treatment for this study

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion Criteria 1. Age 18 years or above 2. Eyes that undergo phaco-trabeculectomy 3. Patient able and willing to give informed consent to phaco-trabeculectomy with intra-vitreal injection of bevacizumab. Exclusion criteria 1. Single functional eye 2. Pregnant patients 3. Patients refusing phaco-trabeculectomy or bevacizumab injection 4. Use of anticoagulants or anti-platelet therapy other than aspirin/NSAIDs within 14 days of surgery. 5. Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-03-25

21 Target Sample Size

50

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Intra-ocular pressure

24 Secondary Outcome

1. Bleb morphology (with photographic record) 2. Visual acuity 3. Number of IOP-lowering medications 4. Corneal clarity and corneal endothelial cell count (by specular microscopy) 5. Posterior capsular opacification 6. Progression in glaucomatous optic neuropathy and visual field loss 7. Any complications from surgery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-04-17

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2008-03-20